Icos Corp · 8-K · For 1/29/04 · EX-99

Filed On 1/29/04 3:55pm ET   ·   SEC File 0-19171   ·   Accession Number 1157523-4-751

Current Report   ·   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Icos 8-K                                               2     10K 
 2: EX-99       Exhibit 99 Press Release                               4     22K 

EX-99   ·   Exhibit 99 Press Release

EX-99
1st Page of 4
TOC
Top
Previous
Next
Bottom
Just 1st
 
Sponsored Ads...


                                                              EXHIBIT 99

     Date:      January 29, 2004
                       Refer to:  (317) 276-5795 - Terra Fox (Lilly)
                                        (425) 415-2207 - Lacy Fitzpatrick (ICOS)

 Lilly ICOS LLC Reports Results for 2003
-- Cialis(R) 2003 worldwide sales exceed $200 million --

BOTHELL, Wash. and INDIANAPOLIS, Ind.--January 29, 2004--Lilly ICOS LLC (Lilly  
ICOS), a 50/50 joint venture between ICOS Corporation (Nasdaq:ICOS) and Eli     
Lilly and Company (NYSE:LLY), which is marketing Cialis(R) (tadalafil) for the  
treatment of erectile dysfunction (ED), is releasing its financial results for  
the year and fourth quarter ended December 31, 2003.                            

During 2003, Cialis was launched around the world. The commercial launches began
in Europe in early February and continued throughout the year. U.S. approval    
occurred on November 21, 2003, and physician detailing and pharmacy stocking    
began immediately thereafter. Cialis also became available in pharmacies in     
Mexico, in August 2003, and in Canada late in November 2003.                    

                                                        [Enlarge/Download Table]


Cialis Product Sales Highlights for 2003 (in millions):                                      
-------------------------------------------------------                                      
                                                            Fourth Quarter         Full Year 
Sales in Lilly ICOS Joint Venture Territories:              --------------         --------- 
                                                                                             
         United States                                               $27.9             $27.9 
         Europe (1)                                                   30.4              95.1 
         Canada and Mexico                                             4.6               6.8 
                                                        -------------------------------------
                  Total Lilly ICOS                                    62.9             129.8 

Sales in Lilly-Only Territories                                       31.3              73.5 
                                                        -------------------------------------
                  Worldwide Total                                    $94.2            $203.3 
                                                        =================== =================

--------------------------------                                                
(1)  Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland,      
  Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden
and the United Kingdom.                                               

-1- 

EX-99
2nd Page of 4
TOC
1st
Previous
Next
Bottom
Just 2nd

"The first phase of the U.S. launch was executed with speed and precision. Sales
representatives met with physicians the first business day after approval.      
Product was shipped from the manufacturing facility within two business days,   
and Cialis was on the shelves in most pharmacies within two weeks," stated Khoso
Baluch, Lilly's U.S. Business Unit Leader for Cialis. "Building awareness and   
motivating men with ED to ask for Cialis are now the top priorities. Brand      
awareness advertising was rolled out in mid-January 2004. Consumer advertising  
with the profile and benefits of Cialis -- critical in reaching ED patients and 
emphasizing Cialis' unique profile -- will debut at the Super Bowl."            

"Patients tell us that they value the distinctive attributes of Cialis,         
particularly that it has been shown to improve erectile function, compared to   
placebo, for up to 36 hours following dosing," commented Leonard Blum, ICOS     
Corporation Vice President of Sales and Marketing. "Cialis provides the patient 
and his partner the freedom to choose the time for intimacy that is right for   
them."                                                                          

2003 Full-Year Financial Results                                                
--------------------------------                                                

For the year ended December 31, 2003, Lilly ICOS reported a net loss of $174.7  
million, compared to a net loss of $131.3 million for the year ended December   
31, 2002.                                                                       

In its first year on the market, 2003 worldwide net product sales of Cialis     
totalled $203.3 million, of which $129.8 million represent sales in Lilly ICOS  
joint venture territories and $73.5 million represent sales in Lilly-only       
territories. Total Lilly ICOS revenue was $144.5 million, including $14.7       
million in royalties on Cialis sales reported by Lilly.                         

Cialis has successfully captured a significant share of unit (tablet) sales     
in Europe among the three PDE5 inhibitors [Cialis, Viagra(R) (sildenafil) and   
Levitra(R) (vardenafil)]. For November 2003, based on pharmacy purchases from   
wholesalers(2), Cialis had a 35% share in France, 30% in Germany, 27% in Italy  
and 16% in both Spain and the United Kingdom. And, through November 2003, those 
markets continue to grow at healthy rates(2) - ranging from 22% in Italy up to  
40% in Germany.                                                                 

Cost of sales totalled $12.5 million in 2003, including royalties payable by    
Lilly ICOS equal to five percent of its net product sales.                      

Selling, general and administrative expenses increased $167.4 million, from     
$75.7 million in 2002, to $243.1 million in 2003. The increase primarily        
reflects the substantial selling and marketing activities associated with the   
2003 launches of Cialis in Europe, beginning in early February, and North       
America later in the year.                                                      

--------                                                                        

(2)  IMS Health. IMS MIDAS, Copyright 2003. Growth rates are based on           
three-month moving total tablet inflow to pharmacies.                 

-2- 

EX-99
3rd Page of 4
TOC
1st
Previous
Next
Bottom
Just 3rd

Research and development expenses increased $8.0 million, to $63.6 million, in  
2003, primarily related to post-marketing clinical studies in Europe, and       
clinical pharmacology studies in the U.S.                                       

2003 Fourth Quarter Financial Results                                           
-------------------------------------                                           

For the three months ended December 31, 2003, Lilly ICOS reported a net loss of 
$57.7 million, compared to a net loss of $42.4 million for the three months     
ended December 31, 2002.                                                        

Worldwide net sales of Cialis totalled $94.2 million in the fourth quarter of   
2003, of which $62.9 million represent sales in Lilly ICOS joint venture        
territories and $31.3 million represent sales in Lilly-only territories. Total  
Lilly ICOS revenue was $69.2 million, including $6.3 million in royalties on    
Cialis sales reported by Lilly.                                                 

Total expenses increased $84.5 million, to $126.8 million, in the fourth quarter
of 2003, reflecting the cost of selling and marketing activities associated with
the 2003 launches of Cialis in North America and Europe.                        

About Lilly ICOS LLC                                                            
--------------------                                                            

Lilly ICOS LLC is a joint venture between ICOS Corporation and Eli Lilly and    
Company.                                                                        

Eli Lilly and Company, a leading innovation-driven corporation, is developing a 
growing portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from       
collaborations with eminent scientific organizations. Headquartered in          
Indianapolis, Indiana, Lilly provides answers - through medicines and           
information - for some of the world's most urgent medical needs.                

ICOS Corporation, a biotechnology company, is dedicated to bringing innovative  
therapeutics to patients. Headquartered in Bothell, Washington, ICOS is         
marketing its first product, Cialis (tadalafil), for the treatment of erectile  
dysfunction. ICOS is working to develop treatments for serious unmet medical    
conditions such as interstitial cystitis, chronic obstructive pulmonary disease,
cancer and inflammatory diseases.                                               

 ###

Except for historical information contained herein, this press release contains 
forward-looking statements within the meaning of the Private Securities         
Litigation Reform Act of 1995. Such forward-looking statements are based on     
current expectations, estimates and projections about the industry, management  
beliefs and certain assumptions made by the management of ICOS and Lilly.       
Investors are cautioned that matters subject to forward-looking statements      
involve risks and uncertainties, including economic, competitive, governmental, 
technological, legal and other factors discussed in the two companies'          
respective filings with the Securities and Exchange Commission, which may affect
the business and prospects of the two companies and Lilly ICOS. Results and the 
timing and outcome of events may differ materially from those expressed or      
implied by the forward-looking statements in this press release. More           
specifically, there can be no assurance that Cialis will achieve commercial     
success or that competing products will not pre-empt market opportunities that  
might exist for the product.                                                    

-3- 

EX-99
Last Page of 4
TOC
1st
Previous
Next
Bottom
Just 4th

The forward-looking statements contained in this press release represent ICOS'  
and Lilly's judgment as of the date of this release. ICOS and Lilly undertake no
obligation to publicly update any forward-looking statements.                   

 --Selected financial data follows--

                                                        [Enlarge/Download Table]


                                 Lilly ICOS LLC                                                                
                 Condensed Consolidated Statements of Operations                                               
                                 (in thousands)                                                                
                                   (unaudited)                                                                 

                                                Three Months Ended                     Year Ended              
                                                   December 31,                       December 31,             
                                          -------------------------------  ------------------------------------
                                               2003           2002               2003              2002        
                                          -------------------------------  ------------------------------------
Revenue:                                                                                                       

                                                                                                               
     Product sales, net                       $    62,911      $       -        $    129,828       $         - 
     Royalties                                      6,263              -              14,705                 - 
                                          -------------------------------  ------------------------------------
         Total revenue                             69,174              -             144,533                 - 
                                          -------------------------------  ------------------------------------

Expenses:                                                                                                      
     Cost of sales                                  5,966              -              12,543                 - 
     Selling, general & administrative            103,025         22,580             243,110            75,697 
     Research and development                      17,858         19,782              63,622            55,641 
                                          -------------------------------  ------------------------------------
         Total expenses                           126,849         42,362             319,275           131,338 
                                          -------------------------------  ------------------------------------

Net loss                                      $  (57,675)      $ (42,362)        $  (174,742)      $  (131,338)
                                          ===============================  ====================================


-4- 

Dates Referenced Herein   and   Documents Incorporated By Reference

				Referenced-On Page
This 8-K Filing		Date		First		Last			Other Filings
		12/31/02		2		3			10-K
		11/21/03		1
		12/31/03		1		3			10-K
Filed On / Filed As Of / For The Period Ended		1/29/04		1					424B3, 4, 3
Top									List All Filings